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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01744613
Date of registration:	05/12/2012
Prospective Registration:	No
Primary sponsor:	University of Patras
Public title:	High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures PRECLOP
Scientific title:	Clinical Impact of High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures. The PRECLOP Study (Platelet REsponsiveness to CLOpidogrel Treatment After Peripheral Angioplasty or Stenting)
Date of first enrolment:	January 2010
Target sample size:	100
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT01744613
Study type:	Observational [Patient Registry]
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Greece

Contacts

Name:	Stavros Spiliopoulos, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Patras University Hospital

Name:	Dimitrios Karnabatidis, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Patras University Hospital

Name:	Georgios Pastromas, MD
Address:
Telephone:
Email:
Affiliation:	Patras University Hospital

Name:	Konstantinos Katsanos, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Patras University Hospital

Name:	Dimitrios Siablis, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Patras University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled
to undergo femoropopliteal or and infrapopliteal angioplasty or stenting.

- Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year
after the procedure.

Exclusion Criteria:

- Acute limb ischemia

- Coagulation disorders

- Known allergy to clopidogrel

- Failure to comply with the antiplatelet treatment protocol

- Aortoiliac disease

Age minimum: 18 Years
Age maximum: 84 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influence of PRU Values on Primary Outcome

Intervention(s)

Primary Outcome(s)

Major event-free survival [Time Frame: 12 months]

Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition [Time Frame: 12 months]

Secondary Outcome(s)

Bleeding rate [Time Frame: 12 months]

Positive and negative predictive value of PRU testing [Time Frame: 12 months]

Secondary ID(s)

822

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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